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CaP Bone Substitute Material is an implantable bone graft, that is a synthetic, calcium phosphate, hydroxyapatite material intended for use in the filling, repair, reconstruction and auqmentation of burr holes, contiguous craniotomy cuts, and other defects in craniofacial bones including fronto-orbital, malar and mental areas, with a surface area no larger than 25cm².

Calcium Phosphate (CaP) Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. It is intended for use in cranial-maxillo-facial surgical repair applications. At the time of use, the CaP product material is combined with the mixing liquid (U.S.P. Sodium Chloride, 0.9%) in the elastomeric mixing bulb, and is mixed, using a kneading technique, to form a paste. The paste can be administered to the treatment site by manual application, and be shaped in situ or into a desired form prior to implantation. After applying the paste to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order and has a similar chemical identity and crystalline structure to that of natural bone. CaP Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.

This document describes a 510(k) premarket notification for a medical device, the CaP Bone Substitute Material. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a typical AI/software device submission would.

This submission is for a material (bone substitute) and relies on demonstrating substantial equivalence to a previously approved predicate device, not on analytical or clinical performance metrics measured against specific acceptance criteria.

Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types for test/training sets, training set sample size, ground truth establishment) is not applicable to this type of submission as it's typically provided for diagnostic or AI-powered devices.

Here's an explanation based on the provided text, highlighting what is (and isn't) present:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable. This submission is for a bone substitute material, not a diagnostic or AI-powered device. The basis for approval is "substantial equivalence" to a predicate device (α-BSM® Bone Substitute Material, K983009), meaning it is considered as safe and effective as a legally marketed device. The document does not describe quantitative acceptance criteria or performance metrics in terms of sensitivity, specificity, accuracy, or similar measures typically associated with AI/software device studies.
• The comparison is based on "intended use," "material properties," and "product performance characteristics" being similar to the predicate device, and that "Differences between the CaP and a-BSM products do not raise any new questions of safety and effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. There is no "test set" in the context of an analytical or clinical performance study for an AI/software device described here. The submission relies on a comparison to a predicate device, which would have had its own original testing, but details of that testing are not in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not Applicable. There is no "test set" and thus no ground truth established by experts for such a set described in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI/software device. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an AI/software device. No standalone performance study is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable. As this is a material rather than a diagnostic or AI device, the "ground truth" concept in the context of a performance study does not apply. The inherent properties and safety/effectiveness of the material are assessed through established testing methods for biocompatibility, mechanical properties, and clinical performance (often by comparison to existing materials or through animal/human studies if new safety questions are raised). This document indicates "product performance characteristics" were compared to the predicate.

8. The sample size for the training set:

• Not Applicable. No "training set" exists as this is not an AI/software device.

9. How the ground truth for the training set was established:

• Not Applicable. No "training set" exists and thus no ground truth for it.

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